EUCTR2007-005752-16-GB进行中（未招募）1 期
A Cancer Research UK randomised phase II trial of ATN-224 (copper binding agent) in combination with exemestane versus exemestane alone in post-menopausal women with recurrent or advanced, oestrogen and/or progesterone receptor positive breast cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 111
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Histologically proven oestrogen and/or progesterone receptor positive breast cancer as defined by at least one of the criteria below:-
- •Oestrogen Receptor Positivity
- •a score of 3 or more on a scale (range of 0 to 8), or equivalent score from other grading methods; representing the intensity and percentage of positive-staining tumour cells by immunohistochemistry.
- •= 5 fmol/mg protein by ligand binding assay or ELISA.
- •Progesterone Receptor Positivity
- •a score of 3 or more on a scale (range of 0 to 8) ), or equivalent score from other grading methods; representing the intensity and percentage of positive-staining tumour cells by immunohistochemistry.
- •2. Patients with recurrent or advanced disease who have received an anti-oestrogen and/or non steroidal aromatase inhibitor as adjuvant treatment or patients who have received an anti-oestrogen or a non-steroidal aromatase inhibitor as first line treatment for advanced disease.
- •3. Post-menopausal women as defined by one of the following:
- •surgical or radiation-induced, bilateral oophorectomy at least 1 year in the past;
- •in women with an intact uterus, no menstrual periods for 12 consecutive months with no other biological or physiological cause;
- •age 55 years or older;
- •4. Measurable/evaluable disease as measured by clinical examination, X-ray, computerised tomography (CT) or MRI scan, with at least one lesion that can be followed for response.
- •5. Life expectancy of at least 6 months.
- •6. Prior therapy allowed:
- •Adjuvant or neoadjuvant treatment with tamoxifen
- •Adjuvant or neoadjuvant treatment with a non-steroidal aromatase inhibitor
- •Adjuvant/neoadjuvant chemotherapy
- •Tamoxifen or non-steroidal aromatase inhibitor as first line treatment in the metastatic setting
- •7. Patients with bone metastases only are eligible provided they have at least one lytic lesion (not previously irradiated or planned for irradiation) that can be followed by X-ray or CT scanning. Independent review of X-ray/CT scans will be performed.
- •8. Patients with cutaneous skin metastases only are eligible provided the skin lesions are > 10 mm and can be followed by good quality photography (ideally performed by medical photography) with a ruler included in the photograph.
- •9. World Health Organisation (WHO) performance status of 0 to 2
- •10. 18 years or over.
- •11. Written (signed and dated) informed consent, and be capable of co-operating with treatment and follow-up.
- •12. Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week before the patient starts study treatment.
- •Lab Test Value required
- •Haemoglobin (Hb) =9.0 g/dl
- •Neutrophils =1.5 x 10(9)/L
- •Platelets =100 x 10(9)/L
- •Serum bilirubin =1.5 x upper limit of normal (ULN)
- •Alanine amino-transferase (ALT) and/or aspartate amino-transferase (AST)
- •= 2.5 x ULN, unless raised due to tumour in which case up to 5 x ULN is
排除标准
- •1. Radiotherapy (except to control pain or prevent fracture or in the adjuvant setting). Chemotherapy except in the adjuvant setting.
- •2. Tumours with HER2 over-expression [3+ score as assessed by immunohistochemistry] or HER2 gene amplification [positive result by fluorescence in situ hybridisation (FISH)].
- •3. Prior treatment with exemestane.
- •4. Currently receiving treatment with a luteinizing hormone-releasing hormone (LH-RH) analogue.
- •5. Currently receiving treatment with oral bisphosphonates (i.v. bisphosphonates are permitted).
- •6. Currently receiving chronic steroid therapy for concurrent illness or cancer. [Short-term steroid use for concurrent illness is allowed, eg for acute asthma].
- •7. History of malabsorption syndromes or other gastrointestinal disorders that may affect ATN-224 absorption, including bowel obstruction, celiac disease, sprue, cystic fibrosis
- •8. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ATN-224, omeprazole (or other proton pump inhibitor), or exemestane.
- •9. Receiving any other copper-binding drug during the study (eg penicillamine or trientine).
- •10. Use of copper- or zinc-containing vitamins or supplements during the study.
- •11. Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or certain Grade 1 toxicities that in the opinion of the Investigator and the Drug Development Office (DDO) should not exclude the patient.
- •12. Clinically apparent brain metastases.
- •13. Major thoracic and/or abdominal surgery in the preceding four weeks from which the patient has not recovered.
- •14. At high medical risk because of non-malignant systemic disease including active uncontrolled infection.
- •15. Known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).
- •16. Current malignancies of other types, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. [Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for 5 years and are deemed at low risk for recurrence, are eligible for the study].
- •17. Concurrent congestive heart failure or prior history of class III/IV cardiac disease (New York Heart Association [NYHA]).
- •18. Any other condition which in the Investigator’s opinion would not make the patient a good candidate for the clinical trial.
- •19. Is a participant or plans to join in another interventional clinical study, whilst taking part in this Phase II study of ATN-224. Participation in an observational study would be acceptable.
研究者
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